Dataset Information

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch.

ABSTRACT:

Background

Low-intensity Continuous Ultrasound (LICUS) therapy heals soft tissue injuries. It alleviates acute and chronic musculoskeletal pain by activating multiple healing processes through its diathermic and mechanotransducive properties. Diclofenac has been FDA-approved as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is an analgesic and anti-inflammatory drug available in oral and topical forms. Adding 2.5% diclofenac sodium to ultrasound coupling gel can be used to deliver LICUS in addition to the analgesic effects of diclofenac sodium without altering the diathermic and acoustic effects of the ultrasound penetration with no undesired adverse effects.

Objective

To determine the effects of adding 2.5% diclofenac sodium to standard aqueous ultrasound gel on the ultrasound coupling and diathermic properties of a long duration Sustained Acoustic Medicine (SAM) treatment.

Methods

In a two-phase study, first, the acoustic and diathermic changes were determined in bovine tissue during 4-hour-long SAM stimulation at 1 cm, 2 cm, and 5 cm with aqueous and 2.5% diclofenac ultrasound coupling patch. Then, in the second phase, the heating profiles were recorded with and without 2.5% diclofenac gel in 54 healthy adult subjects at the forearm and calf during the SAM treatment.

Result

The addition of 2.5% diclofenac sodium significantly increased coupling gel density, acoustic impedance, and signal propagation (p<0.0001) with little or no effect on the diathermic profiles at 1 cm, 2 cm, and 5 cm depth. The coupling gel with 2.5% diclofenac sodium sustained the therapeutic ultrasound intensity longer than the aqueous coupling gel (5.5 cm relative to 4.5, p<0.0009). No significant diathermic difference was recorded on the calf and forearm skin with a 2.5% diclofenac ultrasound gel coupling patch.

Conclusion

Adding 2.5% diclofenac sodium to ultrasound gel increases acoustic impedance, improves ultrasound signal coupling into deep tissue, and provides longer sustained deep tissue heating without negatively impacting the diathermic profile during SAM treatment.

SUBMITTER: Hendren TF

PROVIDER: S-EPMC10485907 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch.

Hendren Tabitha F TF Yeretzian Natalie R NR Bavanasi Kiranmayee K

International journal of physical medicine & rehabilitation 20230620 6

<h4>Background</h4>Low-intensity Continuous Ultrasound (LICUS) therapy heals soft tissue injuries. It alleviates acute and chronic musculoskeletal pain by activating multiple healing processes through its diathermic and mechanotransducive properties. Diclofenac has been FDA-approved as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is an analgesic and anti-inflammatory drug available in oral and topical forms. Adding 2.5% diclofenac sodium to ultrasound coupling gel can be used to deliver LI ...[more]

PMID: 37692795

Similar Datasets

Project description:BackgroundSustained Acoustic Medicine (SAM) is an emerging, non-invasive, non-narcotic, home-use ultrasound therapy for the daily treatment of joint pain. The aim of this multi-site clinical study was to examine the efficacy of long-duration continuous ultrasound combined with a 1% diclofenac ultrasound gel patch in treating pain and improving function in patients with knee osteoarthritis.MethodsThe Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two (32) patients (18-males, 14-females) 54 years of average age with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence (KL) grade II/III) were enrolled for treatment with the SAM device and diclofenac patch applied daily to the treated knee. SAM ultrasound (3 MHz, 0.132 W/cm2, 1.3 W) and 6 grams of 1% diclofenac were applied with a wearable device for 4 hours daily for 1 week, delivering 18,720 Joules of ultrasound energy per treatment. The primary outcome was the daily change in pain intensity using a numeric rating scale (NRS 0-10), which was assessed prior to intervention (baseline, day 1), before and after each daily treatment, and after 1 week of daily treatment (day 7). Rapid responders were classified as those patients exhibiting greater than a 1-point reduction in pain following the first treatment. Change in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score from baseline to day 7 was the secondary functional outcome measure. Additionally, a series of daily usability and user experience questions related to devising ease of use, functionality, safety, and effectiveness, were collected. Data were analyzed using t-tests and repeated measure ANOVAs.ResultsThe study had a 94% retention rate, and there were no adverse events or study-related complaints across 224 unique treatment sessions. Rapid responders included 75% of the study population. Patients exhibited a significant mean NRS pain reduction over the 7-day study of 2.06-points (50%) for all subjects (n=32, p<0.001) and 2.96-points (70%) for rapid responders (n=24, p<0.001). The WOMAC functional score significantly improved by 351 points for all subjects (n=32, p<0.001), and 510 points for rapid responders (n=24, p<0.001). Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms.ConclusionSustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery.Clinical Trial Registry Number: (NCT04391842).

Project description:BackgroundPatients diagnosed with osteoarthritis (OA) and presenting with symptoms are seeking conservative treatment options to reduce pain, improve function, and avoid surgery. Sustained acoustic medicine (SAM), a multi-hour treatment has demonstrated improved clinical outcomes for patients with knee OA. The purpose of this analysis was to compare the costs and effectiveness of multi-hour SAM treatment versus the standard of care (SOC) over a 6-month timeframe for OA symptom management.MethodsA decision tree analysis was used to compare the costs and effectiveness of SAM treatment versus SOC in patients with OA. Probabilities of success for OA treatment and effectiveness were derived from the literature using systematic reviews and meta-analyses. Costs were derived from Medicare payment rates and manufacturer prices. Functional effectiveness was measured as the effect size of a therapy and treatment pathways compared to a SOC treatment pathway. A sensitivity analysis was performed to determine which cost variables had the greatest effect on deciding which option was the least costly. An incremental cost-effectiveness plot comparing SAM treatment vs. SOC was also generated using 1000 iterations of the model. Lastly, the incremental cost-effectiveness ratio (ICER) was calculated as the (cost of SAM minus cost of SOC) divided by (functional effectiveness of SAM minus functional effectiveness of SOC).ResultsBase case demonstrated that over 6 months, the cost and functional effectiveness of SAM was $8641 and 0.52 versus SOC at: $6281 and 0.39, respectively. Sensitivity analysis demonstrated that in order for SAM to be the less expensive option, the cost per 15-min session of PT would need to be greater than $88, or SAM would need to be priced at less than or equal to $2276. Incremental cost-effectiveness demonstrated that most of the time (84%) SAM treatment resulted in improved functional effectiveness but at a higher cost than SOC.ConclusionIn patients with osteoarthritis, SAM treatment demonstrated improved pain and functional gains compared to SOC but at an increased cost. Based on the SAM treatment ICER score being ≤ $50,000, it appears that SAM is a cost-effective treatment for knee OA.

Dataset Information

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch.

Background

Objective

Methods

Result

Conclusion

Publications

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch.

Similar Datasets

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